The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for Rheumajet Rf.
| Device ID | K910539 |
| 510k Number | K910539 |
| Device Name: | RHEUMAJET RF |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | BIOKIT USA, INC. CAN MALE LLISSA D'AMUNT Barcelona, ES 08186 |
| Contact | Ignacio Odriozola |
| Correspondent | Ignacio Odriozola BIOKIT USA, INC. CAN MALE LLISSA D'AMUNT Barcelona, ES 08186 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-28 |
| Decision Date | 1991-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613647001295 | K910539 | 000 |
| 00613647001264 | K910539 | 000 |
| 00613647001257 | K910539 | 000 |